Position Sensing Unit for Medical Lead Navigation
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Solution Overview
Problem
Current medical procedures for implanting devices like pacemakers require the use of imaging devices that expose patients and staff to ionizing radiation, are costly, and necessitate extensive training, limiting the number of facilities that can perform these procedures due to the need for expensive equipment and complex imaging techniques.
Innovation Solution
A position sensing unit (PSU) system that maps and illustrates anatomical regions by determining the location of electrodes within the body using impedance calculations, allowing for navigation and placement of medical leads without the need for external imaging devices like fluoroscopes, reducing radiation exposure and costs.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscope imaging devices are used for lead implantation, then precise positioning of electrodes can be achieved, but patients and staff are exposed to ionizing radiation and the procedure becomes costly
Solution Approach 1:
The patent extracts the imaging function from external fluoroscope devices and implements it within the implantable medical device itself through a position sensing unit. This eliminates the need for separate imaging equipment that exposes patients to radiation, while maintaining the capability to determine lead and electrode positions through impedance measurements.
Solution Approach 2:
The patent introduces impedance measurements as an intermediary method to determine electrode positions without direct visual imaging. By measuring electrical impedance between the electrodes and surrounding tissue, the system can infer positional information alternatively to fluoroscopic imaging, thereby avoiding radiation exposure.
2Ease of operation
If fluoroscope imaging devices are used for lead implantation, then real-time imaging guidance is available, but the equipment cost and training requirements increase significantly
Solution Approach 1:
The patent merges the imaging guidance functionality into the implantable medical device itself by integrating a position sensing unit. This combination eliminates the need for separate, expensive fluoroscope equipment and reduces facility requirements, making the procedure accessible to more facilities without sacrificing real-time positioning capability.
Solution Approach 2:
The implantable medical device performs self-positioning verification through its integrated position sensing unit that continuously monitors lead and electrode positions via impedance measurements. This self-service capability eliminates the need for external imaging equipment and operators trained in complex fluoroscopic techniques.
3Loss of information
If external imaging devices are used during implantation, then anatomical structure visualization is achieved, but the procedure time and facility requirements increase
Solution Approach 1:
The patent extracts the anatomical visualization capability from external imaging devices and implements it through the position sensing unit that uses impedance measurements to infer anatomical structures and lead positions. This approach provides necessary anatomical information without requiring separate imaging procedures that extend procedure time.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The PSU system enables precise navigation and placement of medical leads within the body without external imaging, reducing radiation exposure, costs, and training requirements, making complex procedures more accessible to facilities.
Implementation Method 1
The tracking element can be an electrode and a position is determined by generating a voltage in a patient and calculating an impedance at the electrode. The calculated impedance is used to determine the position of the electrode as in a patient or other appropriate conducting medium.
Data Source
AI summary
An volume of a patient can be mapped with a system operable to identify a plurality of locations and save a plurality of locations of a mapping instrument. The mapping instrument can include one or more electrodes that can sense a voltage that can be correlated to a three dimensional location of the electrode at the time of the sensing or measurement. Therefore, a map of a volume can be determined based upon the sensing of the plurality of points without the use of other imaging devices. An implantable medical device can then be navigated relative to the mapping data.